FDA 510(k)

BPhase、HPO Exotic、LPI、LP2、LP3、マスターサン360、マスターサン360 新レフラー、ベガルックス

K番号: K152233 · 2016-01-27

決定日2016-01-27

製品コードLEJ

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux is the device name listed in this FDA 510(k) record. The listed applicant is Sportarredo Group S.C.. It received FDA 510(k) clearance on 2016-01-27 under 510(k) number K152233. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux?

BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux is a medical device that received FDA 510(k) clearance on 2016-01-27. The listed applicant is Sportarredo Group S.C.. The 510(k) number is K152233.

When did BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux receive FDA 510(k) clearance?

BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux received FDA 510(k) clearance on 2016-01-27, under 510(k) number K152233.

Who is the listed applicant for BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux?

The FDA 510(k) record lists Sportarredo Group S.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux?

The FDA product code for BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux is LEJ.

申請者としてSportarredo Group S.C.を記載するその他の記録

K161394HPOエキゾチック、LP1、LP2、LP3、マスターサン360、マスターサン360ニューレフラクター、ベガラックス

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。